510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834306Substantially Equivalent

Phasix-High Frequency Generator

Cgr Medical Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834306 is the FDA 510(k) clearance record for PHASIX-HIGH FREQUENCY GENERATOR, a class I device, cleared for Cgr Medical Corp. on under FDA product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic). FDA records list 20 510(k) clearances for Cgr Medical Corp., from to . As of , FDA records show no recalls naming K834306.

Clearance record

Decision date
Received
(55 days to decision)
Product code
ITY Assembly, Tube Housing, X-Ray, Diagnostic
Regulation
21 CFR 892.1760
Device class
Class I
Review panel
Radiology
Applicant
Cgr Medical Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code ITY

Trailing 12 months

FDA records hold no clearances under product code ITY in the trailing twelve months.

FDA records show no clearances under product code ITY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ITY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260